BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1666312 · Received April 25, 2010

    Report

    Report Number
    2015691-2010-13210
    Event Type
    Death
    Date Received
    April 25, 2010
    Report Date
    March 25, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OPERATIVE REPORT FOR THE DATE OF (B) (6) 2003 WAS RECEIVED. NO FURTHER DETAILS REGARDING THIS EVENT WAS LEARNED. THE CAUSE OF DEATH AND DATE OF DEATH REMAIN UNKNOWN. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. NO FURTHER DETAILS WERE REPORTED. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS LEARNED. THE CAUSE OF DEATH REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 3C0520

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death